Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.
Adult
Critical Pathways
/ organization & administration
Developing Countries
Early Diagnosis
Female
Humans
Maternal Health Services
/ standards
Maternal Mortality
Medical Order Entry Systems
/ statistics & numerical data
Outcome and Process Assessment, Health Care
Postpartum Hemorrhage
/ diagnosis
Pregnancy
Referral and Consultation
/ statistics & numerical data
Time-to-Treatment
/ standards
Vital Signs
Bleeding
Obstetric haemorrhage
Referral
Resource allocation
Shock index
Triage
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
21 Apr 2021
21 Apr 2021
Historique:
received:
17
12
2020
accepted:
16
03
2021
entrez:
22
4
2021
pubmed:
23
4
2021
medline:
20
5
2021
Statut:
epublish
Résumé
Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).
Sections du résumé
BACKGROUND
BACKGROUND
Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds.
METHODS
METHODS
This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities.
RESULTS
RESULTS
Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy).
CONCLUSIONS
CONCLUSIONS
Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings.
TRIAL REGISTRATION
BACKGROUND
This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).
Identifiants
pubmed: 33882864
doi: 10.1186/s12884-021-03796-4
pii: 10.1186/s12884-021-03796-4
pmc: PMC8061003
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
317Subventions
Organisme : Medical Research Council
ID : MR/N006240/1
Pays : United Kingdom
Références
Control Clin Trials. 1986 Sep;7(3):177-88
pubmed: 3802833
Lancet Glob Health. 2014 Jun;2(6):e323-33
pubmed: 25103301
Lancet Glob Health. 2018 Jan;6(1):e57-e65
pubmed: 29241615
BMC Public Health. 2005 Jun 15;5:67
pubmed: 15958170
Lancet Glob Health. 2019 Mar;7(3):e347-e356
pubmed: 30784635
BMC Pregnancy Childbirth. 2009 Aug 11;9:34
pubmed: 19671156
Trop Doct. 2012 Apr;42(2):101-3
pubmed: 22431828
BMC Pregnancy Childbirth. 2018 Apr 27;18(1):115
pubmed: 29703254
BJOG. 2015 Jan;122(2):268-75
pubmed: 25546050
Int J Obstet Anesth. 2009 Oct;18(4):320-7
pubmed: 19733052
Am J Public Health. 2012 Mar;102(3):480-5
pubmed: 22390511
BMJ Innov. 2018 Oct;4(4):192-198
pubmed: 30319784
Lancet. 2006 Oct 7;368(9543):1284-99
pubmed: 17027735
Reprod Health. 2016 Sep 30;13(Suppl 2):105
pubmed: 27719683
Hum Resour Health. 2016 Oct 26;14(1):65
pubmed: 27784298
Trials. 2011 Apr 20;12:100
pubmed: 21507237
Soc Sci Med. 1994 Apr;38(8):1091-110
pubmed: 8042057
Blood Press Monit. 2015 Feb;20(1):52-5
pubmed: 25243711
Obstet Gynecol. 2011 Jan;117(1):21-31
pubmed: 21173641
Blood Press Monit. 2008 Dec;13(6):342-8
pubmed: 19020425
Acta Obstet Gynecol Scand. 2019 Sep;98(9):1178-1186
pubmed: 31001814
Blood Press Monit. 2015 Oct;20(5):299-302
pubmed: 26020367
PLoS One. 2016 Dec 20;11(12):e0168535
pubmed: 27997586
Int J Gynaecol Obstet. 2013 Dec;123(3):254-6
pubmed: 24054054
Implement Sci. 2008 Dec 17;3:52
pubmed: 19091100